Voriconazole Pfizer 200 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Voriconazole

Available from:

Pfizer Healthcare Ireland

ATC code:

J02AC; J02AC03

INN (International Name):

Voriconazole

Dosage:

200 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Triazole derivatives; voriconazole

Authorization status:

Not marketed

Authorization date:

2013-06-07

Patient Information leaflet

Page 1 of 10 2020-0059891, 2019-0050301,
2020-0059895, 2019-0050034, 2020-0060839
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE PFIZER® 50 MG FILM-COATED TABLETS
VORICONAZOLE PFIZER® 200 MG FILM-COATED TABLETS
voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Voriconazole Pfizer is and what it is used for
2.
What you need to know before you take Voriconazole Pfizer
3.
How to take Voriconazole Pfizer
4.
Possible side effects
5.
How to store Voriconazole Pfizer
6.
Content of the pack and other information
1.
WHAT VORICONAZOLE PFIZER IS AND WHAT IT IS USED FOR
Voriconazole Pfizer contains the active substance voriconazole.
Voriconazole Pfizer is an antifungal
medicine. It works by killing or stopping the growth of the fungi that
cause infections.
It is used for the treatment of patients (adults and children over the
age of 2) with:

invasive aspergillosis (a type of fungal infection due to
_Aspergillus sp_
),

candidaemia (another type of fungal infection due to
_Candida sp_
) in non-neutropenic patients
(patients without abnormally low white blood cells count),

serious invasive
_Candida sp._
infections when the fungus is resistant to fluconazole (another
antifungal medicine),

serious fungal infections caused by
_Scedosporium sp._
or
_Fusarium sp_
. (two different species of
fungi).
Voriconazole Pfizer is intended for patients with worsening, possibly
life-threatening, fungal infections.
Prevention of fungal infections in high risk bone marr

Summary of Product characteristics

Health Products Regulatory Authority
20 April 2022
CRN00CPWZ
Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Pfizer 200 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg voriconazole.
Excipient with known effect
Each tablet contains 253.675 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Voriconazole Pfizer 200 mg film-coated tablets
White to off-white, capsule-shaped tablet, debossed "Pfizer" on one
side and "VOR200" on the reverse (tablets).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Voriconazole Pfizer is a broad-spectrum, triazole antifungal agent and
is indicated in adults and children aged 2 years and
above as follows:
Treatment of invasive aspergillosis.
Treatment of candidaemia in non-neutropenic patients.
Treatment of fluconazole-resistant serious invasive _Candida_
infections (including _C. krusei_).
Treatment of serious fungal infections caused by _Scedosporium_ spp.
and _Fusarium_ spp.
Voriconazole Pfizer should be administered primarily to patients with
progressive, possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
hematopoietic stem cell transplant (HSCT) recipients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and
hypocalcaemia should be monitored and corrected, if
necessary, prior to initiation and during voriconazole therapy (see
section 4.4).
Voriconazole Pfizer is also available as 50 mg film-coated tablets,
200 mg powder for solution for infusion and 40 mg/ml
powder for oral suspension.
Treatment
_Adults _
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral Voriconazole Pfizer to achieve
plasma concentrations on Day 1 that are close to steady state. On the
basis of the high oral bioavailability (96%; see section
5.2), switching between intravenous and oral administration is
appropriate w